Summary:
Have T2DM in accordance with ADA guidelines [1] and be ≥ 18 years of age on the day of signing the ICF.
- Meet one of the following criteria:
On metformin monotherapy ≥1500 mg/day for ≥ 8 weeks with a Visit 1/Screening
A1C ≥ 7.5% and ≤11.0% (≥ 58 mmol/mol and ≤ 97 mmol/mol)
OR
On metformin monotherapy ≥ 1500 mg/day for <8 weeks with a Visit 1/Screening A1C ≥7.5% and ≤ 11.0% ( ≥ 58 mmol/mol and ≤ 97 mmol/mol)
OR
On metformin monotherapy <1500 mg/day with a Visit 1/Screening A1C ≥ 8.0% and ≤11.5% (≥ 64 mmol/mol and ≤102 mmol/mol)
- Have a body mass index (BMI) ≥ 18.0 kg/m2.
- Have personally signed and dated the ICF indicating that he/she has been informed of all pertinent aspects of the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Meet one of the following criteria:
- Subject is a male
- Subject is a female not of reproductive potential defined as one who: (1) Is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age, or (2) Has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Visit 1/Screening c. Subject is a female of reproductive potential and:
(1) agrees to remain abstinent from heterosexual activity (if this form of birth
control is accepted by local regulatory agencies and ethics review committees as
the sole method of birth control for subjects participating in clinical trials), or
(2) agrees to use (or have her partner use) acceptable contraception to prevent
pregnancy while receiving blinded investigational product and for 14 days after
the last dose of blinded investigational product. Two methods of contraception
will be used to avoid pregnancy. Acceptable combinations of methods include:
- Use of one of the following double-barrier methods: diaphragm with
spermicide and a condom; cervical cap and a condom; or a contraceptive
sponge and condom.
- Use of hormonal contraception (any registered and marketed contraceptive
agent that contains an estrogen and/or a progestational agent [including oral,
subcutaneous, intrauterine and intramuscular agents, and cutaneous patch])
with one of the following: diaphragm with spermicide; cervical cap;
contraceptive sponge; condom; vasectomy; or IUD.
- Use of an IUD with one of the following: condom; diaphragm with
spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see
above).
- Vasectomy with one of the following: diaphragm with spermicide; cervical
cap; contraceptive sponge; condom; IUD; or hormonal contraception (see
above).
Qualified Participants May Receive:
$50 at each completed visit for up to 11 total visits.